FDA's ISTAND Pilot Program accepts submission of first artificial intelligence based and digital health technology for neuroscience

23 January 2024 - FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research recently accepted a ...

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FDA establishes new advisory committee on digital health technologies

11 October 2023 - Today, the US FDA announced the creation of a new Digital Health Advisory Committee to help ...

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FDA outlines plan for digital health technologies for clinical trials

24 March 2023 - The US FDA plans to hold at least one public meeting and release several guidances on digital ...

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Digital health predictions: uncertainty will trigger innovation in 2023

7 February 2023 - It was an interesting year for digital health.  ...

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Click Therapeutics receives FDA breakthrough device designation for prescription digital therapeutic to treat episodic migraine

16 December 2022 - Click Therapeutics today announced that it has received breakthrough device designation from the US FDA for ...

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How digital health innovators can successfully navigate evolving FDA regulations

19 October 2022 - In the rapidly changing landscape of digital health, innovation has often outpaced regulations, especially for novel ...

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Amazon versus Apple: only one will rewrite the rules of health care

29 August 2022 - Big tech has had a surprisingly small impact on U.S. healthcare, so far. ...

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Regulatory considerations to keep pace with innovation in digital health products

19 August 2022 - Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital ...

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Visibly becomes first FDA cleared online vision test in the United States

16 August 2022 - Visibly is excited to announce that, as of 12 August  2022, it has received 510(k) clearance ...

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Pear Therapeutics receives safer technologies program designation from FDA for product candidate to treat acute and chronic pain

13 April 2022 - Pear Therapeutics today announced it has received safer technologies program for medical devices designation from the ...

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FDA officials aim to stop misuse of the term ‘digital biomarker’

29 March 2022 - While a lot of researchers claim they are capturing digital biomarker data, they may in fact be ...

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Digital Therapeutics should be regulated with gold standard evidence

28 February 2022 - There is enormous growth in the digital health sector, illustrated by huge capital investment, and a massive ...

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DynamiCare Health digital therapeutic receives FDA breakthrough device designation for treatment of smoking during pregnancy

23 February 2022 - If approved, DynamiCare’s DCH-001 would become the first prescription treatment for smoking cessation demonstrated to be safe ...

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Apple iPhone game changing new health feature cleared by FDA, coming in weeks

20 February 2022 - A new app is coming this spring which will be game changing for diabetes care.  ...

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How digital therapeutics platforms are revolutionising health care delivery

17 February 2022 - With enormous advances in digital health innovation, we are quickly moving into an age where software platforms ...

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